A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy

Postoperative Pain Clinical Trial

Official title:

The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06425601
• Other study ID #: 0120-445/2019/8
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: August 10, 2023

Study information

• Verified date: May 2024
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.

The main questions it aims to answer are:

• silicone chest drains are less painful compared to standard PVC drains?

• is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary lung cancer eligible for VATS lobectomy by tumor board meeting

Exclusion Criteria:

• age under 18 years

• high risk of post-operative complications (ASA > 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) = 40%, cycle ergometry with oxygen consumption (VO2 max) < 15 ml/kg/min)

• tumors growing in parietal pleura

• extended lung resection diffuse

• previous surgery in the same hemithorax

• chronic pain

• chronic use of analgesics or sedatives

• surgical revision

• inability to participate in the study.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Complications
• Postoperative Pain

Intervention

Device:
• SIL drain
Silicone chest tube used for pleural space drainage after VATS lobectomy
• PVC drain
Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesics consumption	Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome.	2 days
Primary	Need for peroral analgesia after the chest tube removal	Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome.	2 days
Primary	Maximal inspiratory pressure	Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome.	2 days
Primary	Maximal expiratory pressure	Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome.	2 days
Primary	Visual analogue scale	Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome.	2 days
Secondary	Duration of chest drainage	The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome.	1 month
Secondary	Pneumothorax rate on the day of surgery	The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.	First day
Secondary	Pneumothorax rate after chest tube removal	The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.	1 month
Secondary	Pleural effusion rate on the day of surgery	The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.	First day
Secondary	Pleural effusion rate after chest tube removal	The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.	1 month
Secondary	Subcutaneous emphysema rate	The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome.	1 month
Secondary	Prolonged air leak rate	The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome.	1 month
Secondary	Reintervention rate	The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome.	1 month
Secondary	Duration of hospital stay	Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome.	1 month
Secondary	Respiratory complication rate	Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome.	1 month
Secondary	Readmission rate	Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome.	1 month